.png)
With ICH E6(R3) set to take effect this July, sponsors are under new pressure to transform oversight from a documentation exercise into an active, ongoing responsibility. But what does it take to put the guidance into practice?
Join GCP expert Donna Dorozinsky and TruTechnologies Director of Product Bryce Lugar for a practical discussion on how sponsors can align with the updated guideline — without losing sight of operational realities. Topics will include:
Why data governance must be actionable — sponsors are expected to implement clear processes for reviewing data and responding to risks
How risk management should be proactive — oversight strategies need to be tied to sponsor-driven risk frameworks from the start, not added after problems surface
How improved data visibility enables sponsors to detect protocol deviations earlier and fulfill their oversight responsibilities more effectively
